EUGIA PHARMA SPECLTS FDA Approval ANDA 213885

ANDA 213885

EUGIA PHARMA SPECLTS

FDA Drug Application

Application #213885

Application Sponsors

ANDA 213885EUGIA PHARMA SPECLTS

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005
None (Tentative Approval)006

Application Products

002CAPSULE; ORAL5MG0LENALIDOMIDELENALIDOMIDE
003CAPSULE; ORAL10MG0LENALIDOMIDELENALIDOMIDE
004CAPSULE; ORAL15MG0LENALIDOMIDELENALIDOMIDE
005CAPSULE; ORAL20MG0LENALIDOMIDELENALIDOMIDE
006CAPSULE; ORAL25MG0LENALIDOMIDELENALIDOMIDE

FDA Submissions

UNKNOWN; ORIG1TA2021-12-09STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

EUGIA PHARMA SPECLTS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213885
            [companyName] => EUGIA PHARMA SPECLTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"2.5MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"5MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"10MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"15MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"20MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"25MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-08
        )

)

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